FDADecember 11, 2014device

MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect. Those units include the IFU for the MENTOR MemoryShape Resterilizable Sizer.

What to do

FDA enforcement status: Terminated

Brands named

mentor texas lpmentormentor texas

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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